| Primary Device ID | 00850005949350 |
| NIH Device Record Key | 70af72a1-1168-4c85-b823-e2d1cf49e5d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton |
| Version Model Number | KIT-BBR-3763-3 |
| Company DUNS | 116984478 |
| Company Name | BIOINTELLISENSE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005949343 [Primary] |
| GS1 | 00850005949350 [Package] Contains: 00850005949343 Package: Master Carton (MC) [50 Units] In Commercial Distribution |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-24 |
| Device Publish Date | 2023-11-16 |
| 00850005949534 - BioButton Adhesive V2 (ADH-CS) | 2024-05-09 BioButton Cold Seal Adhesive V2 (ADH-CS) |
| 00850005949336 - BioButton At-Home Kit with Power Adaptor | 2023-11-24 BioButton At-Home Kit with Power Adaptor |
| 00850005949350 - BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton | 2023-11-24BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton |
| 00850005949350 - BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton | 2023-11-24 BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton |
| 00850005949374 - BioButton At-Home Kit with Adhesives and BioButton | 2023-11-24 BioButton At-Home Kit with Adhesives and BioButton |
| 00850005949398 - BioButton At-Home Kit | 2023-11-24 BioButton At-Home Kit |
| 00850005949411 - BioButton At-Home Kit with Power Adaptor and Adhesives | 2023-11-24 BioButton At-Home Kit with Power Adaptor and Adhesives |
| 10850005949227 - BioButton v3 (BBN-r, different batch, Individual Pack) | 2023-10-06 Note: 00850005949220 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from d |
| 00850005949299 - BioButton v3 (BBN-r, different batch) | 2023-09-13 Note: 00850005949299 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from d |